MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3005
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An impella cp device was attempted via the right femoral artery in a patient presenting with acute myocardial infarction complicated by cardiogenic shock.The patient¿s current status is reported as stable.According to the physician, the insertion event was related to the equipment because the impella cp was advanced into the left ventricle, but the 0.018-inch wire could not be withdrawn from the device.The pump was therefore removed because the wire could not be extracted.Non-operational log data could not be provided.The patient did not have a known history of vascular disease such as peripheral vascular disease or aortic stenosis, and there was no noted vessel flexion that would have made insertion difficult.Imaging was used to evaluate the vessel diameter prior to the procedure.The team was able to advance the device to the left ventricle, but the 0.018-inch wire could not be removed and the device could not be operated.The deployment sheath did pull to the catheter plug, and the wire tip was shaped.No specific point of resistance was identified.The patient had no known history of peripheral artery disease, and no difficulties were encountered when inserting the placement guidewire into the guidewire induction tube.The reported events are difficult to advance and medical device removal.The impella cp will be conservatively reported for serious injury due to temporary interruption of hemodynamic support during the device removal; however, the removal was performed with no consequence to the patient, and support was resumed without any known adverse events.
Additional Manufacturer Narrative
Investigation summary: difficult/unable to remove through other device: the cause of difficult/unable to remove through other device cannot be determined since insufficient clinical details were provided.
Additional Manufacturer Narrative
Corrected data a150207 removed from h6.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; abeno-ku; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24707125
• Report Number: 1220648-2026-06011
• Device Sequence Number: 13371864
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(10)8854002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3005
• Device Lot Number: 8854002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian